What Determines a Positive Outcome of Spinal Manipulation for Persistent Low Back Pain: Stiffness or Pain Sensitivity? A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Subjective low back pain
研究概览
简要总结
Introduction Several treatment methods have been proposed to ease the burden of low back pain (LBP) but none are clearly superior. Spinal manipulative therapy (SMT) is a guideline recommended treatment, but the effect is moderate to low. Previous publications suggest that acute LBP patients with who are more stiff are more likely to improve with SMT. However, as LBP persists changes in the central nervous system which modulates the pain experience becomes hypersensitive and possible stiffness is not as important an factor. Experimentally SMT may have a reversible effect of this sensitization.
Objective The primary objective of this study is, to examine whether SMT is more effective in regards to short term pain relief when directed at level in the lower back characterized by spinal stiffness or pain hypersensitivity in persistent LBP.
Methods A double blinded randomized clinical trial of up to 155 participants with persistent LBP included at a multidisciplinary Spinecenter. spinal stiffness (Global Stiffness Score) is measured using the VerteTracker, a novel device that can quantify stiffness. Pain sensitivity is measured as pain threshold, tolerance, temporal summation (TS) and conditioned pain modulation(CPM).
Participants receive SMT at either "the stiffest" or "the most sensitive" segment, a total of four times over a 14-day period. The quantitative measures are recorded at baseline, post treatment and at 4-weeks follow-up along with a numerical pain rating (NRS) and the a disability index (ODI).
Discussion These novel findings could improve clinical decision rules - specifically at which level in the lower back to direct SMT. Furthermore, the results will potentially shed light on the underlying mechanisms of SMT - are treatment effects mediated primarily by changes in stiffness or central hypersensitivity?
详细描述
1.0 Background 1.1 Treatment of persistent low back pain Low back pain (LBP) is one of the leading causes of years lived with disability. In Denmark, many patients are treated conservatively in private practice via general practitioner, chiropractor and physiotherapist. It is well known that LBP often is recurrent or chronic condition. Patients with LBP often report pain relief following spinal manipulation although clinical and research findings are mixed . There is clear evidence that spinal manipulation is able to give short term pain relief, increase range of motion and the clinical outcomes are comparable to other common interventions for persistent LBP. Unfortunately, there are no reliable means to determine beforehand whether spinal manipulation is likely to provide pain relief for a given patient and it is common practice to simply try a series of treatments to assess the effect.
1.2 Segmental dysfunctions Spinal manipulation is directed at spinal mechanical dysfunctions. However, reliably identifying mechanically dysfunctional segments has proven difficult. In an attempt to objectively quantify such dysfunctions, a mechanical spinal indentation apparatus,, the VerteTrack (VT) has been developed and when compared to the generally unreliable palpation findings of an experienced clinician, no correlation was found.
Without reliable and objective indicators of the presence of spinal dysfunctions, clinical trials of spinal manipulation are bound to include both patients with and without biomechanical dysfunction, thus potentially obscuring any effect of spinal manipulation in the treatment of such dysfunctions. This heterogeneity in the experimental groups could, at least in part, explain the conflicting evidence.
To address this, a preliminary study has compared quantified spinal stiffness measured by VT and the outcome of spinal manipulation which reported a positive correlation between objectively quantified spinal stiffness and clinical improvement following manipulation in a cohort of acute LBP patients. The study suggests that VT may potentially serve to identify a subgroup of patients with LBP, who also has a higher probability of a positive response to manipulative treatment.
1.3 Factors complicating treatment of persistent low-back pain After the onset of low-back pain, the central neural pathways which conduct, modulate and integrate the pain stimulus changes over time as pain persists and becomes more excitable: It is evident that the nociceptive receptors become hyperexcitable, leading to increased transmission of nociceptive sensory input, which in turn causes central hypersensitive and possibly an attenuation of descending pain-inhibiting mechanisms. Overall, this results in enhanced local pain responses (hyperalgesia) and sometimes widespread increased pain sensitivity (generalized hyperalgesia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be enrolled in the study, the participant must fulfill the following:
- •Informed written consent
- •Have the ability to speak and read Danish.
- •Between the age of 18 and
- •Body mass index < 35
- •LBP > 3 months, defined as pain on the posterior aspect of the body between the 12th thoracic vertebrae and the gluteal folds.
- •No previous back surgery and must not have had surgery in general in the last 4 months.
- •Must not have received spinal manipulation in the last month.
- •Must not take other pain medication than paracetamol, NSAIDs or weak synthetic opioids
- •Not have radiculopathy: dermatomal leg pain and a positive straight-leg-raise test <60 degrees.
- •Not have problems regarding deep vein thrombosis, circulatory issues in the under extremity, compartment syndrome or severe lung diseases
- •No competing diagnoses which could a) confound the diagnosis of NSLBP e.g. osteoporosis, cancer, fibromyalgia etc. b) interfere with the allocated treatment or c) interfere with QST and VT testing
排除标准
- •Participants will be excluded during the study if:
- •Not completing the allocated intervention (minimum 75% of scheduled treatments).
- •Receiving other treatment than that administered as part of the study
- •Deviate from the agreed upon medication at baseline measures within the treatment period.
- •Inability to hold breath for 10 seconds
研究组 & 干预措施
Pain group
The segment on the lower back marked as "most painful"
干预措施: Spinal manipulation (Other)
Stiff group
The segment on the lower back marked as "most stiff"
干预措施: Spinal manipulation (Other)
结局指标
主要结局
Subjective low back pain
时间窗: Baseline (day 0), Post treatment(day 14), Follow-up(28 days)
Pain: will be measured by the Low Back Pain Rating scale (NRS) consisting of an 11-point box score. Changes in pain will be measured at each time point
次要结局
- Disability(Baseline (day 0), Post treatment(day 14), Follow-up(28 days))
- Low back stiffness (Global stiffness)(Baseline (day 0), Post treatment(day 14), Follow-up(28 days))
- Low back pressure pain threshold(Baseline (day 0), Post treatment(day 14), Follow-up(28 days))
- Heat pain threshold(Baseline (day 0), Post treatment(day 14), Follow-up(28 days))
- Quantitative sensory testing(Baseline (day 0), Post treatment(day 14), Follow-up(28 days))
研究者
Casper Glissmann Nim
MSc, Ph.D student
Spine Centre of Southern Denmark
